NCT05946044Recruiting
The Osteoarthritis Prevention Study
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1230 (estimated)
- First submitted
- 6 Jul 2023
- Start date
- 21 Mar 2024
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Wake Forest University
- Diseases
- Obesity
- NCT number
- NCT05946044
What you commit to
- Study type: Interventional
- Planned participants: 1230
- From 21 Mar 2024 to the primary completion date, 31 Jul 2029
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial collateral ligament (MCL), or meniscus injury with or without surgical repair
Other illness
- symptomatic or severe coronary artery disease
- type 1 diabetes
- active treatment for cancer
Other
- unable to walk without a device
- blindness
- knee injection during the past 6 months
- bilateral knee OA by x-ray Kellgren-Lawrence (KL) ≥ 2
- bilateral knee OA by MRI
- bilateral symptomatic knee OA (frequent bilateral knee pain \> 15 days per month)
- BMI\< 30.0 kg/m2
- male sex
- claustrophobia
- contraindication to MRI including body weight \> 300 lbs or knee coil does not fit
- unwillingness or inability to change eating and physical activity habits due to environment
- cannot speak and read English
- planning to leave area \> 2 months during the 48-month intervention period
Who the study is looking for
- Female
- BMI ≥ 30 kg/m2
- An eligible knee will have no OA by xray and MRI
- No or infrequent knee pain (\< 15 days/month) in the same knee
Age in the registry: 50 years to - · Sex: Female · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Active, not recruiting |
| Wake Forest University Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.